MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Vercise Genus?; stimulator, electrical, implanted, for parkinsonian tremor

Model Number	DB-1216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient implanted with a deep brain stimulation (dbs) system passed away.The cause of death is unknown.No further information has been obtained.
Event or Problem Description
It was reported that a patient implanted with a deep brain stimulation (dbs) system passed away.The cause of death is unknown.No further information has been obtained.Additional information was received stating that the cause of death was not reported and remains unknown.According to the physician, the death was not considered related to the device.The physician was also unable to identify any recent procedure that may have caused or contributed to the patient's death.No information was available regarding an autopsy, and no significant comorbidities believed to have contributed to the patient's death were identified by the physician.No further information has been obtained.
Additional Manufacturer Narrative
Block b2 and b3: approximated based on the date the manufacturer became aware of the event.Block d.2b; additional applicable product codes: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-4600-c serial number: na batch/lot number: 36076470 model/catalog description: suretek burr hole cover kit unique identifier (udi) #: (b)(4).Model number/catalog number: db-2202-45 serial number: (b)(6).Batch/lot number: 7096147 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) #: (b)(4).Model number/catalog number: db-2202-45 serial number: (b)(6).Batch/lot number: 7134862 model/catalog description: dbs directional lead sterile kit 45cm unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55 serial number: (b)(6) batch/lot number: 7134360 model/catalog description: 55cm 8 contact extension unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55 serial number: (b)(6).Batch/lot number: 7134314 model/catalog description: 55cm 8 contact extension unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Correction to the initial mdr in block(s) h11.Block d.2b; additional applicable product codes: nhl, pjs.Additional suspect medical device components involved in the event: model number/catalog number: db-4600-c, serial number: na, batch/lot number: 36076470, model/catalog description: suretek burr hole cover kit, unique identifier (udi) #: (b)(4).Model number/catalog number: db-2202-45, serial number: (b)(6), batch/lot number: 7096147, model/catalog description: dbs directional lead sterile kit 45cm, unique identifier (udi) #: (b)(4).Model number/catalog number: db-2202-45, serial number: (b)(6).Batch/lot number: 7134862.Model/catalog description: dbs directional lead sterile kit 45cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55, serial number: (b)(6), batch/lot number: 7134360, model/catalog description: 55cm 8 contact extension, unique identifier (udi) #: (b)(4).Model number/catalog number: nm-3138-55, serial number: (b)(6), batch/lot number: 7134314, model/catalog description: 55cm 8 contact extension, unique identifier (udi) #: (b)(4).

• Brand Name: Vercise Genus?
• Common Device Name: stimulator, electrical, implanted, for parkinsonian tremor
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50201397
• Report Number: 3006630150-2026-05738
• Device Sequence Number: 10436479
• Product Code: MHY
• UDI-Device Identifier: 08714729985044
• UDI-Public: (01)08714729985044(17)270325(10)787716
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 787716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Sex: Male